There are about 849 clinical studies being (or have been) conducted in Uganda. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Platform study to evaluate the efficacy and safety of anti-malarial agents in patients with uncomplicated Plasmodium falciparum malaria
This clinical study is a phase 4, single-site, open-label pharmacokinetic (PK) study of IV artesunate in up to 100 Ugandan children 6 months-14 years of age who are diagnosed with severe malaria according to standardized World Health Organization (WHO) criteria (any P. falciparum parasitemia and the presence of danger signs). Participants will receive the standard of care IV artesunate for initial treatment of severe malaria per WHO guidelines: children weighing <20 kg should receive 3.0 mg/kg/dose compared to children weighing =20 kg who should receive 2.4 mg/kg/dose, at times 0, 12, 24, 48 and 72 hours (WHO 2015). Parenteral treatment will be administered for a minimum of 24 hours (irrespective of the patient's ability to tolerate oral medication earlier), after which patients will be evaluated clinically and assessed for ability for oral intake of antimalarials. Children who are able to transition to oral antimalarial therapy will initiate a 3-day course of artemisinin-combination oral therapy per national guidelines. The primary objective of the study is to determine the relationship between DHA exposures following IV artesunate dosing and markers of physiologic dysfunction associated with severe malaria in Ugandan children.
The goal of this clinical trial is to determine if twice daily oral penicillin prophylaxis is non-inferior to monthly IM penicillin prophylaxis in preventing latent Rheumatic Heart Disease Progression in children between the ages of 5-17 years. The main objective is to compare the proportion of children aged 5-17 years with latent RHD receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive IM penicillin prophylaxis.
The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetic of the combination M5717 plus pyronaridine in participants with acute uncomplicated Plasmodium falciparum malaria. Pyramax (Artesunate/Pyronaridine) will act as an internal control providing reference safety data and a benchmark for the efficacy evaluation.
In Uganda, Youth living with HIV/AIDS (YLHIVA) enrolled in HIV treatment experience suboptimal treatment adherence and have lower viral load suppression (VLS) rates compared to younger children or adults. VLS is essential in reducing AIDS related morbidity and mortality yet AIDS-related deaths remain high among YLHIVA. To improve these poor outcomes, there has been an effort by Ministry of Health Uganda (MoH) to prioritize and scale up new adolescent and youth-targeted models of service delivery. "Peer support" increasingly forms part of adolescent and youth-responsive service packages as a class of implementation strategies that can support adolescents to access, engage, and sustain treatment. However, peer support activities in Uganda occur face to face at health care settings(2). This approach presents structural limitations such as the need to travel or schedule an appointment, inconvenient working hours and inadequate safe space for peer support activities. Thus, peer support services may not be readily available at the time when youth need them. With the rapid increase in mobile phone availability among Ugandan youth, online peer support groups (PSGs) have the potential to help YLHIVA access regular support without significant effort or cost. The rollout of online PSGs among YLHIVA in Uganda requires evidence on there acceptability feasibility and effectiveness. Aim: The aim of this study is to explore a WhatsApp peer support group as a strategy to improve ART adherence care among youth aged 15-24 years in Kampala district. Methods: The study will use a mixed methods approach. It will be conducted in two phases; first a formative phase to refine the aspects of the WhatsApp peer support group. These findings will then guide the design and implementation of the second phase; an RCT to assess the acceptability, feasibility and effectiveness of WhatsApp PSG as strategy to improve ART adherence among YLHIVA in Kampala. The RCT is a multicentre, open label assessor-blind, with balanced randomisation (1:1) parallel group superiority trial. Study participants randomized to the control arm will remain on the current standard of care only, while those in the intervention arm will be enrolled on a WhatsApp PSG and receive the current standard. Data will be collected using structured questionnaires, Key Informant Interviews, focus group discussions and in-depth interviews. Quantitative data will be analysed using summary statistics, logistic regression models, generalized linear models and Generalized Estimating Equations while for the qualitative verbatim transcription and thematic analysis will be used. Utility: The study findings will help to advance the knowledge on virtual support as a peer support model in Uganda.
Lactating women requiring treatment for uncomplicated malaria will be identified and invited for sampling. The decision to treat them with first-line treatment will have been made by the clinician, not by a member of the study team. The study team will not make any adjustments to the prescribed treatment. Artemether-lumefantrine comprises six doses of medication, with the initial two doses given 8 hours apart on Day 1, and dosing 12-hourly on Day 2 and Day 3. Intensive pharmacokinetic sampling will be undertaken after Dose 5, as indicated in the schema under Section 5: plasma and breastmilk samples will be obtained pre-dose and at 2, 4, 6, 8 hours after dose. In addition, sparse sampling will be undertaken on either of these occasions; at pre-dose and between 1 to 6 hours after the first dose; a trough (pre-dose) sample after the Dose 3 or Dose 4 and lastly at 5, 7, and up to 14-days after the first dose. A heelprick sample will also be obtained from the breastfed infants at maternal trough (prior to maternal dose) and at a random timepoint (once per infant) over the 8-hour pharmacokinetic sampling visit to characterize concentrations of these drugs over an 8-hour dosing interval. In addition, a single heelprick sample will be obtained from the infant whenever the mother returns after treatment for the late sampling time points (5, 7, and 14 days post the first dose). Due to the long half-life of lumefantrine of approximately 6 days plasma sampling will be performed up to day 14 to characterise the terminal elimination of the drug. Concentrations of total plasma and breastmilk lumefantrine and desbutyl-lumefantrine will be determined.
ADAPT is a prospective cohort study at Jinja Regional Referral Hospital (JRRH) primarily to assess the effect of hydroxyurea on blood transfusion utilization and secondarily to determine the feasibility of PK-guided hydroxyurea dosing.
The purpose of the study is to evaluate the pharmacokinetics (PK), safety, tolerability, and acceptability of a long-acting injectable Cabotegravir and Rilpivirine in Virologically Suppressed Children Living with HIV-1, Two to Less Than 12 Years of Age
The goal of this clinical trial is to develop My Mobile Wallet- a behavioral and economic intervention to support tuberculosis treatment adherence in rural southwestern Uganda. The main question[s] it aims to answer are: • Determine the optimal design and develop My Mobile Wallet as an intervention to support tuberculosis medication adherence • Assess the initial feasibility and acceptability of using My Mobile Wallet to support tuberculosis medication. Participants will use My Mobile Wallet intervention for a period of six months. Researchers will compare My Mobile Wallet intervention versus standard care to see if there is an impact on tuberculosis medication adherence.
Effective, cost-effective, scalable, sustainable, and equitable implementation strategies to improve care for people living with HIV and co-morbid hypertension in sub-Saharan Africa are urgently needed. Our study will compare the effectiveness, scalability, and cost-effectiveness of a lower-resource intensive vs. a higher resource intensive strategy to integrate hypertension care into HIV clinics in Uganda.